Quiz 7: Regulatory Oversight-Inspections

1)If a Warning Letter is issued, how many working days from receipt of the warning letter does the Principal Investigator have to respond in writing to the FDA?

1. 1. 7
   2. 15
   3. 5
   4. 10

2. In the U.S., regulatory inspections for clinical research are conducted by:
   1. Sponsors
   2. All answer choices
   3. Institutional Review Boards (IRBs)
   4. Food and Drug Administration

3. You are a FDA Inspector conducting an inspection at a local hospital for a medical device trial. At the end of the day, you meet with the Principal Investigator to discuss your observations. The first observation you discuss is a lack of documentation in each subject’s medical records describing the

informed consent process. Which of the following is an acceptable response by the Principal Investigator?

1. 1. The Principal Investigator states she was not aware of the requirement for documenting the informed consent process in each subject’s medical records
   2. The Principal Investigator states the IRB had previously audited the study and did not note any lack of documentation
   3. The Principal Investigator states this task is the responsibility of the study coordinator
   4. The Principal Investigator states she is 100% responsible for the conduct of the trial and outlines a plan for correcting this lack of documentation and preventing this lack of documentation from reoccurring

4. Which of the following FDA inspections would most likely be considered a “directed” inspection?
   1. Inspection at a site where a bioequivalence study was conducted
   2. Inspection at the highest enrolling site in a study
   3. None of the answer choices.
   4. Inspection at a randomly selected site

5. The FDA Inspector is required to present this document, also known as “Notice of Inspection” at the beginning of an inspection:
   1. Form FDA 1571
   2. Form FDA 1572
   3. Form FDA 483
   4. Form FDA 482

6. Which of the following is NOT a true statement regarding FDA inspections?
   1. Warning Letters issued by the FDA are publically available
   2. FDA Inspectors must have a warrant to inspect investigators and review subjects’ medical records
   3. An investigator cannot deny an FDA inspector access to facilities and study information

1. 4. FDA Inspections can lead to criminal prosecutions and imprisonment

7. You are a FDA Inspector conducting an inspection at a local hospital for a medical device trial. Which of the following is appropriate and therefore is NOT an observation that would be reported on a Warning Letter?
   1. Study Coordinator reported serious adverse events to the IRB as per IRB guidelines
   2. IRB approval was not obtained prior to subject enrollment
   3. Subjects 002, 004, 009, 010, and 015 did not date the signature on the informed consent document
   4. Investigational medical devices were not properly stored and documentation accounting for each device is incomplete
8. At the conclusion of the inspection, the FDA inspector may provide this document, also known as the “List of Inspectional Observations”:
   1. Form FDA 483
   2. Form FDA 1571
   3. Form FDA 482
   4. Form FDA 1572

9. TRUE or FALSE: All FDA centers conduct inspections.
   1. True
   2. False

10. Which of the following classifications of an FDA inspection typically results in the issuance of a Warning Letter?
    1. Disqualification and/or Debarment
    2. Official Action Indicated
    3. Voluntary Action Indicated
    4. No Action Indicated